Clinical Trial: Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
Brief Summary: The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
Detailed Summary:
Sponsor: Retina Research Institute, LLC
Current Primary Outcome: Safety [ Time Frame: 12 months ]
Original Primary Outcome: Incidence and Severity of Adverse Events [ Time Frame: 12 months ]
Current Secondary Outcome:
- Mean visual acuity (BCVA) at Months 6 and 12 [ Time Frame: Month 6 and Month 12 ]
- Mean change in OCT central foveal thickness from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
- Mean change in Macular Volume from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
- Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
- Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
- Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
Original Secondary Outcome: Same as current
Information By: Retina Research Institute, LLC
Dates:
Date Received: April 2, 2012
Date Started: June 2012
Date Completion: December 2015
Last Updated: July 24, 2015
Last Verified: July 2015